System and method for biphasic transdermal iontophoretic delivery of therapeutic agents for the control of addictive cravings

Abstract

Embodiments of the invention provide methods for the transdermal delivery of therapeutic agents for the treatment of addictive cravings e.g., nicotine compounds for the treatment of nicotine cravings from tobacco use. An embodiment of a method for such delivery comprises positioning at least one electrode assembly in electrical communication with a patient's skin. The assembly includes a solution comprising a therapeutic agent which passively diffuses into the skin. A dose of agent is delivered from the assembly into the skin during a first period using a first current having a characteristic e.g., polarity and magnitude, to repel the agent out of the assembly. During a second period, a second current having a characteristic to attract the agent is used to retain the agent in the assembly such that delivery of agent into skin is minimized. A dose of agent may be delivered on demand by an input from the patient.

What is claimed is: 
     
       1. A system for transdermal iontophoretic delivery of a therapeutic agent to reduce an addictive craving in a patient, the system comprising an electrode assembly and a controller, the system configured to:
 position at least one electrode assembly in electrical communication with a skin of the patient, the at least one electrode assembly including a skin contacting layer and a solution comprising the therapeutic agent, wherein the therapeutic agent passively diffuses into the skin of the patient without application of an external force; 
 deliver a dose of the therapeutic agent from the at least one electrode assembly into the skin of the patient during a first period using a first current having a polarity and magnitude to repel the therapeutic agent out of the electrode assembly, wherein delivering a dose of therapeutic agent includes a therapeutic agent delivery profile during the first period configured to mimic a delivery profile from the addictive craving; 
 retain the therapeutic agent in the at least one electrode assembly during a second period using a second current having a polarity and magnitude to retain the therapeutic agent in the electrode assembly such that delivery of the therapeutic agent into the skin during the second period is minimized, wherein the first period comprises a delivery period and the second period comprises a non-delivery period, which together comprise a delivery cycle; and 
 control the delivery cycle, wherein controlling the delivery cycle includes utilizing the controller to deliver or retain the therapeutic agent based on the delivery profile. 
 
     
     
       2. The system of  claim 1 , wherein the therapeutic agent comprises a nicotine compound for treatment of cravings and withdrawal from nicotine dependent addictions. 
     
     
       3. The system of  claim 2 , wherein the therapeutic agent comprises nicotine, a nicotine salt or a nicotine analogue. 
     
     
       4. The system of  claim 1 , wherein the therapeutic agent comprises a compound for treatment of cravings and withdrawal from opioid dependent addictions. 
     
     
       5. The system of  claim 4 , wherein the therapeutic agent comprises a methadone compound. 
     
     
       6. The system of  claim 5 , wherein the methadone compound comprises methadone, a methadone analogue or a methadone derivative. 
     
     
       7. The system of  claim 1 , wherein the therapeutic agent comprises a compound for treatment of cravings and withdrawal from cocaine addiction. 
     
     
       8. The system of  claim 7 , wherein the therapeutic agent comprises acetylcysteine, baclofen, bupropion, vanoxerine, or vigabatrin. 
     
     
       9. The system of  claim 1 , wherein the electrode assembly comprises a first electrode and a therapeutic agent reservoir electrically coupled to the first electrode and fluidically coupled to the skin contacting layer. 
     
     
       10. The system of  claim 9 , wherein the electrode assembly further comprises a second electrode. 
     
     
       11. The system of  claim 1 , wherein the delivery period is initiated by a patient input device, the patient input device generating a signal which is fed into the controller. 
     
     
       12. The system of  claim 11 , wherein the controller includes a control program or other logic for initiating a drug delivery period upon receiving the signal. 
     
     
       13. The system of  claim 12 , wherein the controller maintains the first current for the drug delivery period to deliver a selected dose of the therapeutic agent based on the delivery profile. 
     
     
       14. The system of  claim 13 , wherein the controller stops the first current and starts the second current by generating a holding current. 
     
     
       15. The system of  claim 14 , wherein the controller adjusts a magnitude of the first current or a magnitude of the second current relative to a concentration of the therapeutic agent within the solution. 
     
     
       16. The system of  claim 1 , wherein the delivery profile comprises a profile of an actual use of a chemical compound by the patient that results in the addictive craving of the patient. 
     
     
       17. The system of  claim 1 , wherein the controller is configured to limit a number of doses of therapeutic agent delivered over a selected period. 
     
     
       18. The system of  claim 17 , wherein the selected period is 24 hours. 
     
     
       19. The system of  claim 17 , wherein the therapeutic agent comprises a compound for treatment of nicotine cravings. 
     
     
       20. The system of  claim 17 , wherein the therapeutic agent comprises a compound for treatment of opioid cravings. 
     
     
       21. The system of  claim 17 , wherein the therapeutic agent comprises a compound for treatment of cocaine cravings. 
     
     
       22. The system of  claim 1 , wherein the controller is configured to limit a time interval between delivered doses of the therapeutic agent.